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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K972514
Device Name LASEREX LP1532 PHOTOCOAGULATOR
Applicant
Ellex Medical Pty. Ltd.
258 HALIFAX ST.
ADELAIDE, S.A.,  AU 5000
Applicant Contact KEITH R DEGENHARDT
Correspondent
Ellex Medical Pty. Ltd.
258 HALIFAX ST.
ADELAIDE, S.A.,  AU 5000
Correspondent Contact KEITH R DEGENHARDT
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/07/1997
Decision Date 10/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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